Lecture 9: introduction to research ethics

why was the Nuremberg code developed?

because the Nazi performed atrocities during WW2

what were the new concepts introduced in the Nuremberg code? (4)

• emphasis on the notion of consent

• introduction of voluntary consent (you actually have a choice and aren’t forced)

• experiment must have fruitful results

• avoid unnecessary physical or psychological harm

true or false: if you are a minor, you need parental approval to participate

false: not if you’re over 14

what are the international codes that influenced the Research Ethics Board (REB) in Canada? (3)

• Nuremberg Code

• Helsinki Declaration

• Principles of Biomedical Ethics

true or false: you don’t need to comply to the REB policies if you want to be eligible for federal grants

false

what’s the Research Ethics Board’s role?

to review the ethical acceptability of research involving humans

what are the categories of members composing the REB? (4)

• disciplinary (research focused)

• ethics

• legal

• community members

how can the REB do to protect the participants? (4)

• protect the participants’s rights

• review the research proportionally: more risk = more scrutiny

• balance between the benefits of the research and the possible harm

• review with the participants’s perspective

true or false: the REB can only approve or reject a research

false: it can also request modifications or terminate a research

define “research”

undertaking intended to extent knowledge through a disciplined inquiry of a systematic investigation

define “human participant”

• living human participant whose data or response are relevant to answering the research question

• also includes human biological materials (blood, embryos, stem cells, etc)

what are some research that are excluded from REB review? (4)

• research that relies only on information publicly available

• research involving observation of people in public spaces

• research that relies only on secondary use of anonymous information (no identifiable information)

• research that involves people who aren’t the focus of the research (we only want information)

you can use publicly accessible information without REB review. where could you find these information? (2)

• on websites that are protected by law (ex: stats Canada)

• in domains where the participant themselves shared information (ex: facebook, linkedln)

what are the situations where you don’t need REB approval if observations are made in public spaces? (3)

• doesn’t involved staged intervention or interaction with researcher

• no expectation of privacy

• results won’t identify the person

what are some research that are excluded from REB review? (2)

under which REB review does McGill psychology falls in?

REB 2 reviews

how long does the turnaround time take once you’ve received the initial REB review?

5-6 weeks

what does the turnaround time depend on? (7)

• complexity of the project

• coherence, completeness and consistency of the application

• if it answered every question properly

• if all the required documents are sent

• interview guides, recruitment ads

• signed by applicant and supervisor

• quantity of correction needed

what’s included in a notice of ethics review (NOR)? (2)

• ethical issues that need to be addressed and the possible courses of actions

• clarification or justification that the REB want for a particular method

when can a study be disapproved from the REB?

if the study didn’t meet the criteria for ethical acceptability or if if it’s fundamentally flawed and needs too much revisions

define “minimal risk”

research in which the probability and magnitude of possible harm is not greater than the risk in everyday life

define the core value of “human dignity”

inherent worth of all human beings and the respect and consideration that they are due

what are the principles the core value of human dignity? (3)

• respect for person: free, voluntary, informed and ongoing consent + treat them as a person

• concern of welfare: avoiding exposing the participant to unnecessary risks

• justice: obligation to treat everyone fairly, impartially and equitably

explain the “respect for persons” principle (4)

• autonomy, informed decision

• free, voluntary, informed, ongoing consent

• treat the person as someone and not as a mean to end

• respect the autonomy and protect those with less autonomy

explain the “concern for welfare” principle (4)

• avoid unnecessary exposure to risks

• protect the participant’s confidentiality

• treating the biological material according to the consent of the donor

• think about the effects it could have on the participant and their family/friends

explain the “justice” principle

obligation to treat everyone fairly, impartially, equitably

what’s the difference between fairness and equity?

• fairness: equal respect, no elimination based on differences

• equity: distribution of benefits and burdens across everyone

risk is a function of […] and […] of possible harms

• magnitude: minimal to substantial

• probability: likelihood

true or false: risks are dependent on consent

false

what’s the difference between situational and intrinsic vulnerability?

• situational: right now

• intrinsic: minor, can’t consent

what are the characteristics of consent? (4)

• informed: enough information to make a decision

• comprehension: understand the information

• documentation: usually written, but not always

• free and voluntary: without coercion

true or false: consent is always written out

false: with certain people, verbal consent is better

what are the factors that could undermine your voluntariness (could sway your consent)? (4)

• incentives that make you disregard the risks

• conflicts of interest and dual roles (your prof asking you to participate)

• research involving deception

• capacity (no capacity to consent)

what are the researcher’s responsibilities? (5)

• to ensure that the research is done in an ethical manner

• to protect their participants’ rights and welfare

• to ensure that the research receives the necessary ethics

• to ensure that the research is done according to the university and government policies

• to respect the laws about personal information

when should ethics approval be obtained?

before involving participants (or else it will be refused)

for how long is approval valid before it needs renewal?

one year

what are the study changes that would need a new approval? (6)

• change in research design or methodology

• recruitment procedures

• location of study

• consent procedure

• team member change

• any risk increase for participant